BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1961100 · Received January 12, 2011

    Report

    Report Number
    3004209178-2011-00310
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    April 30, 2010
    Report Date
    January 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD A STAPH INFECTION AT THE TIME OF PUMP IMPLANT. THE PUMP WAS EXPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention CATHETER: MODEL 8709, LOT# J0039645R| EXPLANTED:| IMPLANTED: